In December there were a total of four new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were six supplemental drug approvals. The FDA had assigned eight new products for review.

Drugs included in this review are generally regarded by the industry as specialty drugs. Qualifiers may include anticipated administration by a professional, distribution by a specialty pharmacy or submission and reimbursement under the medical claim or Medicare Part B.

New Specialty Drug Approvals – New FDA drug approvals in the previous month

Drug Name

Manufacturer

Route of Administration

Indication

Approval Date

Herzuma (trastuzumab-pkrb) – Biosimilar

CELLTRION

Intravenous

Treatment of HER2-overexpressing breast cancer

12/14/2018

ASPARLAS™ (calaspargase pegol – mknl)

Servier

Intravenous

An asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years.

In combination with bevacizumab, paclitaxel, and carboplatin, for the first-line treatment of patients with metastatic non-squamous, non-small cell lung cancer (NSq NSCLC), with no EGFR or ALK genomic tumor aberrations.

12/06/2018

Nplate® (romiplostim)

Amgen

Subcutaneous

Treatment of pediatric patients 1 year of age and older with immune thrombocytopenia (ITP) for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

PDUFA: Prescription Drug User Fee Act: a law passed in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. By collecting the fee, the FDA is required to meet benchmarks related to the speed of the NDA/BLA review process

PDUFA Date: deadlines for the FDA to approve new drugs, typically 10 months from NDA/BLA completions, drugs selected for priority review may be allotted 6 months

Todd Cooperman

Todd Cooperman joined RJ Health in June 2016 as Vice President, Clinical Analytics. As Senior Vice President, Todd and his team work with our various clients to identify opportunities and solutions that result in improved medical drug spend and clinical management.